Cost Comparison of Femoral Distraction Osteogenesis with External Lengthening Over a Nail Versus Internal Magnetic Lengthening Nail

Home , Epiphysiodesis

Research Article Cost Comparison of Femoral Distraction Osteogenesis With External Lengthening Over a Nail Versus Internal Magnetic Lengthening Nail

Abstract Shawn S. Richardson, MD Introduction: Femoral lengthening is performed by distraction William W. Schairer, MD osteogenesis via lengthening over a nail (LON) or by using a magnetic lengthening nail (MLN). MLN avoids the complications of external Austin T. Fragomen, MD fixation while providing accurate and easily controlled lengthening. S. Robert Rozbruch, MD However, the increased cost of implants has led many to question whether MLN is cost-effective compared with LON. From the Limb Lengthening and Methods: A retrospective review was performed comparing Complex Reconstruction Service, Hospital for Special Surgery, New consecutive femoral lengthenings using either LON (n = 19) or MLN York, NY. (n = 39). The number of surgical procedures, time to union, and Correspondence to Dr. Richardson: amount of lengthening were compared. Cost analysis was performed [email protected] using both hospital and surgeon payments. Costs were adjusted for Dr. Fragomen or an immediate family inflation using the Consumer Price Index. member is a member of a speakers’ Results: No difference was observed in the length of femoral bureau or has made paid presentations on behalf of NuVasive, Smith & distraction. Patients treated with MLN underwent fewer surgeries Nephew, and DePuy Synthes; serves (3.1 versus 2.1; P , 0.001) and had a shorter time to union as a paid consultant to Globus Medical, (136.7 versus 100.2 days; P = 0.001). Total costs were similar NuVasive, Smith & Nephew, and DePuy Synthes; and serves as a board ($50,255 versus $44,449; P = 0.482), although surgeon fees were member, owner, officer, or committee lower for MLN ($4,324 versus $2,769; P , 0.001). member of the Limb Lengthening Discussion: Although implants are more expensive for MLN Research Society. Dr. Rozbruch or an immediate family member has received than LON, this appears to be offset by fewer procedures. Overall, royalties from Stryker; is a member of a the two procedures had similar total costs, but MLN was ’ speakers bureau or has made paid associated with a decreased number of procedures and shorter presentations on behalf of and serves as a paid consultant to NuVasive, Smith time to union. & Nephew, and Stryker; and serves as a Level of Evidence: III board member, owner, officer, or committee member of the Limb Lengthening Reconstruction Society. Neither of the following authors nor any engthening of the femur has been drawbacks remain, including the risk immediate family member has received performed by using distraction of pin tract infection, pin loosening, anything of value from or has stock or L stock options held in a commercial osteogenesis via the lengthening over a skin traction, regenerate fracture, company or institution related directly or nail (LON) technique,1 involving the regenerate deformity, premature or indirectly to the subject of this article: use of a monorail external fixator to delayed consolidation, and knee Dr. Richardson and Dr. Schairer. lengthen the femur over a femoral and/or hip stiffness.3-6 Although this J Am Acad Orthop Surg 2018;00:1-7 intramedullary nail. This technique technique results in successful out- 1,7 DOI: 10.5435/JAAOS-D-17-00741 results in much less time in the exter- comes for many patients, motor- nal fixator and fewer complications ized intramedullary devices have been Copyright 2018 by the American Academy of Orthopaedic Surgeons. than the classic technique using the developed with the goal of avoiding external fixator alone,2,3 but many many of these complications.

Month 2018, Vol 00, No 00 1

Copyright Ó the American Academy of Orthopaedic Surgeons. Unauthorized reproduction of this article is prohibited. Cost of Femoral Lengthening: Lengthening Over a Nail Versus Magnetic Lengthening Nail

Figure 1

Radiographs depicting treatment with LON and MLN. A through C depict LON: lengthening of the femur using an external fixator and intramedullary nail (A), consolidation of the regenerate after removal of the external fixator (B), and the ultimate removal of the intramedullary nail after union (C). D through F depict MLN: insertion of the MLN (D), consolidation of the regenerate after lengthening was completed (E), and the final result after removal of the nail (F). LON = lengthening over a nail, MLN = magnetic lengthening nail

The introduction of the magnetic skin traction, knee stiffness, and lengthening nail (MLN) has gradually regenerate fracture.5,15,18-20 Fur- Methods led some surgeons to shift their prac- thermore, patients treated with tices toward internal lengthening MLN have been shown to have a Patient Selection techniques.8,9 Initial internal length- shorter mean healing index, allowing All patients who underwent femoral ening nail designs had many of their earlier weight bearing, as well as lengthening via distraction osteo- own complications, including diffi- improved patient satisfaction and genesis at a single institution between culty controlling lengthening rate, perception of the cosmetic result of 2005 and 2014 were included in the mechanical device failure, prema- their surgery.5 These studies have study. All surgical procedures were ture consolidation, and insufficient only reinforced patient and surgeon performed by the two senior authors bone regenerate.10-14 Some studies enthusiasm for the technique. of the study (S.R.R., A.T.F.). All even found that early devices had Although advances in the implant patients had a minimum of 2-year more complications than LON tech- technology have led to improved follow-up. Because of a change in niques.7 However, as the implant patient outcomes with fewer compli- practice preference of the treating design and function has improved cations, the high implant costs associ- surgeons, patients in the earlier sec- over time, more recent studies of ated with MLN may exceed the clinical tion of our period underwent LON improved designs have shown that benefits. The purpose of this study was (n = 19; 2005 to 2009), whereas femoral lengthening via MLN may to determine whether there is a differ- those later in the period underwent be performed reliably with excellent ence in the hospital, surgeon, and total MLN (n = 39; 2012 to 2014). LON precision.15-17 cost between femoral osteogenesis via was performed with an expectation Recent comparative clinical stud- LON or MLN. Furthermore, combin- of three procedures: osteotomy with ies have shown that internal length- ing clinical and cost data, we sought to the insertion of the intramedullary ening via MLN may reduce many of analyze whether there is a difference in nail and application of the external the complications associated with the relative cost-effectiveness of LON fixation, removal of the external LON, such as pin tract infection, and MLN. fixator, and eventual removal of the

2 Journal of the American Academy of Orthopaedic Surgeons

Copyright Ó the American Academy of Orthopaedic Surgeons. Unauthorized reproduction of this article is prohibited. Shawn S. Richardson, MD, et al intramedullary nail. MLN was per- Table 1 formed using the PRECICE nail Demographic, Clinical, and Cost Comparison Between Patients Who (NuVasive) with an expectation of Underwent Treatment With LON Versus MLN two surgical procedures: osteotomy P with insertion of the MLN and Parameters LON MLN Value removal of the MLN. The typical Number 19 39 — treatment protocols, as demon- Female 10.5% 23.1% 0.260 strated by serial radiographs, may be Age (yr) 32.4 6 14.6 29.2 6 13.4 0.412 seen in Figure 1. Length distracted (mm) 41.4 6 23.2 38.5 6 16.7 0.595 Time to union (d, total) 136.7 6 50.4 100.2 6 29.7 0.001a Outcomes Time to union 85.6 6 42.8 57.9 6 31.7 0.008a Patient clinical records were retro- (d, postdistraction) 6 6 , a spectively reviewed, including Total procedures 3.1 0.8 2.1 0.5 0.001 6 6 a demographics, the number of inpa- Inpatient procedures 1.9 1.0 1.3 0.4 0.002 a tient and outpatient surgical proce- Outpatient procedures 1.2 6 0.5 0.8 6 0.5 0.005 a dures performed, total distraction Outpatient office visits 9.3 6 5.8 6.3 6 3.1 0.021 length, and time to bony union. Bony Total hospital costs ($) 45,913 6 35,094 41,680 6 22,345 0.875 union was determined based on con- Total surgeon costs ($) 4,342 6 830 2,769 6 768 ,0.001a tinuity of three of four cortices on AP Total cost 50,255 6 35,103 44,449 6 22,358 0.482 1 and lateral radiographs as well as the (hospital surgeon, $) ability to fully weight bear without LON = lengthening over a nail, MLN = magnetic lengthening nail assistance or discomfort. a Signifies P , 0.05. Cost analysis was performed from the payer perspective. We compiled the total payments received by the hospital data and t-tests for continuous data. tients treated with MLN underwent on for all care related to femoral length- Analyses were performed using STATA average one fewer surgical procedure ening, including surgical, inpatient, (version 14.2; StataCorp). (3.1 versus 2.1; P , 0.001), which and outpatient visits. This total was resulted from both fewer inpatient and included as the total hospital cost paid outpatient procedures (Figure 2). by the payer. For each surgical proce- Results dure performed, the Current Proce- dural Terminology (CPT) codes billed Demographics Costs were recorded and used to calculate an A total of 58 patients were included in The total hospital costs paid were expected surgeon fee using the Medi- the study, 19 of which had undergone similar between the groups ($45,913 care Physician Fee Schedule (https:// LON and 39 who had undergone versus $41,680; P = 0.875). Surgeon www.cms.gov/apps/physician-fee- MLN (Table 1). Most patients were payments were markedly lower for schedule/), represented as the surgeon male, with an average age in the patients treated with MLN ($4,324 , cost. A list of the included CPT codes fourth decade. No notable difference versus $2,769; P 0.001). No nota- can be found in Appendix 1. These was observed in demographics be- ble difference was observed in the total two components were summed to tween the MLN and LON cohorts. payments between the two groups calculate the total cost. To allow dol- ($50,255 versus $44,449; P = 0.482). lar values to be accurately compared Clinical Results A comparison of costs is shown in over the study period, costs were Figure 3. The total length distracted was similar inflation adjusted to be recorded in between groups (LON, 41.4 versus 2015 dollars using the chained Con- MLN, 38.5 mm; P =0.595).Thepa- sumer Price Index (https://data.bls.gov/ Discussion tients treated with MLN had a shorter pdq/SurveyOutputServlet). overall total time to union (136.7 In this retrospective comparison of pa- versus 100.2 days; P = 0.001). In tients undergoing femoral distraction Statistical Analysis addition, the time from distraction osteogenesis via LON or MLN techni- Clinical and cost data were compared completion to final union was shorter ques,treatmentwithMLNresultedin between the LON and MLN groups, forpatientstreatedwithMLN(85.6 lower surgeon costs with no difference using chi-squared tests for categorical versus 57.9 days; P = 0.008). The pain total or hospital costs. Furthermore,

Month 2018, Vol 00, No 00 3

Figure 2 ilar amount of lengthening between the cohorts, our data show that MLN leads to a faster time to union, thus allowing a shorter total treatment time andfasterreturntoweightbearingand activity. These findings echo those of Laubscher et al,5 who found similarly faster time to union for MLN compared to a monorail external fixator system. Furthermore, our data show that patients treated with MLN underwent on average one fewer surgical procedure, thus lowering the number of anesthesia episodes and risks associated therein. This discrepancy in the number of surgical procedures is inherent in the treatment protocols followed for each form of lengthening, as patients undergoing Chart showing the comparison of the number of procedures performed for LON were expected to undergo three patients treated with LON versus MLN. *Signifies P , 0.05. LON = lengthening over a nail, MLN = magnetic lengthening nail procedures compared with two procedures for MLN, and was not a result of an increased number of Figure 3 complication-related procedures. The hospital cost data used in this study were a sum of all payments made to the hospital by the payer, which is a more accurate assessment of cost than total billings, as it reflects what the patient or insurance company actually paid for the treatment received, and thus the direct cost to the healthcare system. The surgeon billing data were calculated based on the Medicare Physician Fee Schedule in an attempt to standardize surgeon fees, as these may vary based on a patient’s insurance plan and the reimbursement schedules for each patient’s corresponding insurance plan were not available for use in this study. Chart showing the comparison of the total, hospital, and surgeon costs for Costs of prolonged treatment with patients treated with LON versus MLN. *Signifies P , 0.05. LON = lengthening over a nail, MLN = magnetic lengthening nail LON exist that we were not able to measure but are important to consider. Patients undergoing LON required the MLN technique resulted in a faster studies, MLN has many advantages additional procedures and prolonged time to final bony union with fewer over LON, including avoiding the use consolidation time compared with surgical procedures. of external fixators. External fixators those undergoing MLN, which likely In addition to similar, if not lower, have many disadvantages, such as resulted in additional time away cost of treatment, our data show that increased pain, skin traction due to pin from work or other activities. Al- treatment with MLN may provide travel, increased hip and knee stiffness, though not accounted for in this a better clinical experience for the risk of pin-site infections, and social study, nevertheless, these indirect costs patient. As has been described in past stigma.3-6 Furthermore, despite a sim- increase the treatment cost to society.

4 Journal of the American Academy of Orthopaedic Surgeons

Copyright Ó the American Academy of Orthopaedic Surgeons. Unauthorized reproduction of this article is prohibited. Shawn S. Richardson, MD, et al

This study does have limitations. The contents. In this article, reference 11 9. Rozbruch SR, Fragomen AT: Lengthening of the femur with a remote-controlled magnetic exact cost of various components of is a level II study. References 3, 5, 7, intramedullary nail: Antegrade technique. the treatment, such as the cost of the and 18 are level III studies. Refer- JBJS Essent Surg Tech 2016;6:1-11. individual implants, was not available. ences 1-2, 4, 6, 8-10, 12-16, 20 are 10. Burghardt RD, Herzenberg JE, Specht SC, The price paid for implants varies from level IV studies. References 17 and Paley D: Mechanical failure of the institution to institution, and our 19 are level V expert opinion. intramedullary skeletal kinetic distractor in limb lengthening. J Bone Joint Surg Br institution could be paying less than 2011;93:639-643. others for the MLN implant. How- References printed in bold type are those published within the past 5 years. 11. Kenawey M, Krettek C, Liodakis E, Meller R, ever, the idea that the price would be Hankemeier S: Insufficient bone regenerate low enough to offset the measured 1. Kim HJ, Fragomen AT, Reinhardt K, after intramedullary femoral lengthening: Risk factors and classification system. Clin Orthop difference in total cost is unlikely. Hutson JJ Jr, Rozbruch SR: Lengthening of the femur over an existing intramedullary Relat Res 2011;469:264-273. Furthermore, we were only able nail. JOrthopTrauma2011;25:681-684. 12. Kenawey M, Krettek C, Liodakis E, to measure direct costs paid by the 2. Sangkaew C: Distraction osteogenesis of Wiebking U, Hankemeier S: Leg payer; indirect or opportunity costs the femur using conventional monolateral lengthening using intramedullay skeletal are not captured in our study. The external fixator. Arch Orthop Trauma Surg kinetic distractor: Results of 57 consecutive applications. Injury 2011;42:150-155. surgeon cost was calculated based on 2008;128:889-899. the reimbursement rates provided by 3. Wan J, Ling L, Zhang XS, Li ZH: Femoral 13. Lee DH, Ryu KJ, Song HR, Han SH: bone transport by a monolateral external Complications of the intramedullary Medicare for the billed CPT codes and fixator with or without the use of skeletal kinetic distractor (ISKD) in thus may differ from and not be ap- intramedullary nail: A single-department distraction osteogenesis. Clin Orthop Relat Res 2014;472:3852-3859. plicable to patients with private payer retrospective study. Eur J Orthop Surg Traumatol 2013;23:457-464. insurance. Additionally, inherent bias 14. Schiedel FM, Pip S, Wacker S, et al: Intramedullary limb lengthening with the may be observed between the two 4. Gordon JE, Manske MC, Lewis TR, O’Donnell JC, Schoenecker PL, Keeler intramedullary skeletal kinetic distractor in groups as they underwent treatment KA: Femoral lengthening over a the lower limb. J Bone Joint Surg Br 2011; at different periods and with variable pediatric femoral nail: Results and 93:788-792. lengths of follow-up. complications. JPediatrOrthop2013; 15. Kirane YM, Fragomen AT, Rozbruch SR: 33:730-736. Precision of the PRECICE internal bone 5. Laubscher M, Mitchell C, Timms A, lengthening nail. Clin Orthop Relat Res Conclusions Goodier D, Calder P: Outcomes 2014;472:3869-3878. following femoral lengthening: An initial 16. Schiedel FM, Vogt B, Tretow HL, et al: How comparison of the Precice intramedullary precise is the PRECICE compared to the The results of this study indicate that lengthening nail and the LRS external ISKD in intramedullary limb lengthening? similar distraction can be achieved with fixator monorail system. Bone Joint J Reliability and safety in 26 procedures. Acta 2016;98-B:1382-1388. the MLN technique compared with the Orthop 2014;85:293-298. LON technique, but with few surgical 6. Song HR, Oh CW, Mattoo R, et al: 17. Rozbruch SR, Birch JG, Dahl MT, Femoral lengthening over an procedures and with a faster time to Herzenberg JE: Motorized intramedullary intramedullary nail using the external nail for management of limb-length final bony union. Despite the increased fixator: Risk of infection and knee problems discrepancy and deformity. J Am Acad cost of implants for the MLN tech- in 22 patients with a follow-up of 2 years or Orthop Surgeons 2014;22:403-409. more. Acta Orthop 2005;76:245-252. nique, the total payments were similar 18. Horn J, Grimsrud O, Dagsgard AH, between the two groups, likely from the 7. Mahboubian S, Seah M, Fragomen AT, Huhnstock S, Steen H: Femoral lengthening Rozbruch SR: Femoral lengthening with with a motorized intramedullary nail. Acta additional procedures and hospital care lengthening over a nail has fewer Orthop 2015;86:248-256. required in the LON technique. complications than intramedullary skeletal kinetic distraction. Clin Orthop Relat Res 19. Paley D: PRECICE intramedullary limb 2012;470:1221-1231. lengthening system. Expert Rev Med Devices 2015;12:231-249. References 8. Fragomen AT, Rozbruch SR: Lengthening of the femur with a remote-controlled 20. Wiebking U, Liodakis E, Kenawey M, Krettek magnetic intramedullary nail: Retrograde C: Limb lengthening using the PRECICETM Evidence-based Medicine: Levels of technique. JBJS Essent Surg Tech 2016;6: nail system: Complications and results. Arch evidence are described in the table of 1-15. Trauma Res 2016;5:e36273.

Month 2018, Vol 00, No 00 5

Appendix 1 A Listing of the CPT Codes Used in the Calculation of Surgeon Fees. Techniques Encounter CPT Code Patients Description

MLN Surgery #1 27466 39 Osteoplasty, femur; lengthening — 27495 39 Prophylactic treatment (nailing, pinning, plating, or wiring) with or without methyl methacrylate, femur Surgery #2 20680 33 Removal of implant; deep (eg, buried wire, pin, screw, metal band, nail, rod or plate) Other codes 11044 1 Débridement, bone (includes epidermis, dermis, subcutaneous tissue, muscle and/or fascia, if performed); first 20 sq cm or less — 20902 1 Bone graft, any donor area; major or large — 27005 1 Tenotomy, hip flexor(s), open (separate procedure) — 27062 1 Excision; trochanteric bursa or calcification — 27305 4 Fasciotomy, iliotibial (tenotomy), open — 27334 1 Arthrotomy, with synovectomy, knee; anterior OR posterior — 27360 1 Partial excision (craterization, saucerization, or diaphysectomy) bone, femur, proximal tibia and/or fibula (eg, osteomyelitis or bone abscess) — 27430 1 Quadricepsplasty (eg, Bennett or Thompson type) — 27450 3 Osteotomy, femur, shaft or supracondylar; with fixation — 27470 1 Repair, nonunion or malunion, femur, distal to head and neck; without graft (eg, compression technique) — 27570 1 Manipulation of knee joint under general anesthesia (includes application of traction or other fixation devices) — 27687 1 Gastrocnemius recession (eg, Strayer procedure) LON Surgery #1 27466 19 Osteoplasty, femur; lengthening — 20692 19 Application of a multiplane (pins or wires in more than 1 plane), unilateral, external fixation system (eg, Ilizarov, Monticelli type) Surgery #2 27495 18 Prophylactic treatment (nailing, pinning, plating, or wiring) with or without methyl methacrylate, femur — 20694 18 Removal, under anesthesia, of external fixation system Surgery #3 20680 16 Removal of implant; deep (eg, buried wire, pin, screw, metal band, nail, rod or plate) Other codes 11044 1 Débridement, bone (includes epidermis, dermis, subcutaneous tissue, muscle and/or fascia, if performed); first 20 sq cm or less — 14020 2 Adjacent tissue transfer or rearrangement, scalp, arms and/or legs; defect 10 sq cm or less — 14021 1 Adjacent tissue transfer or rearrangement, scalp, arms and/or legs; defect 10.1 sq cm to 30.0 sq cm — 20693 1 Adjustment or revision of external fixation system requiring anesthesia (eg, new pin[s] or wire[s] and/or new ring[s] or bar[s]) — 20902 9 Bone graft, any donor area; major or large — 27005 1 Tenotomy, hip flexor(s), open (separate procedure) — 27334 1 Arthrotomy, with synovectomy, knee; anterior OR posterior (continued) CPT = Current Procedural Terminology, LON = lengthening over a nail, MLN = magnetic lengthening nail The typical codes used at each planned surgery throughout the two treatment protocols are delineated, followed by a listing of other codes included in the study.

6 Journal of the American Academy of Orthopaedic Surgeons

Copyright Ó the American Academy of Orthopaedic Surgeons. Unauthorized reproduction of this article is prohibited. Shawn S. Richardson, MD, et al

Appendix 1 (continued) A Listing of the CPT Codes Used in the Calculation of Surgeon Fees. Techniques Encounter CPT Code Patients Description

— 27430 2 Quadricepsplasty (eg, Bennett or Thompson type) — 27472 5 Repair, nonunion or malunion, femur, distal to head and neck; with iliac or other autogenous bone graft (includes obtaining graft) — 27479 1 Arrest, epiphyseal, any method (eg, epiphysiodesis); combined distal femur, proximal tibia and fibula — 38220 1 Bone marrow; aspiration only

CPT = Current Procedural Terminology, LON = lengthening over a nail, MLN = magnetic lengthening nail The typical codes used at each planned surgery throughout the two treatment protocols are delineated, followed by a listing of other codes included in the study.

Month 2018, Vol 00, No 00 7